BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECA INJECTION NEEDLES

    MDR report key: 22814981 · Received August 15, 2025

    Report

    Report Number
    3005581270-2025-00001
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 16, 2025
    Report Date
    October 2, 2025
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K161430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). FOLLOW UP ATTEMPTS WERE MADE TO THE CUSTOMER VIA EMAIL / VOICE MAIL, AND THEY WERE REQUESTED TO PROVIDE ADDITIONAL INFORMATION AND TO COMPLETE THE QUESTIONNAIRE. NO RESPONSE RECEIVED. DEVICE HISTORY RECORD REVIEW: PART MJT-2530-LL LOT 0861414855 WAS BUILT ON WORK ORDER (B)(4). THE DHR SHOWS A TOTAL OF 1,024 SCRAPED NEEDLES OF (B)(4) PRODUCED. THE SCRAP UNITS WERE ACROSS 7 STEPS OF THE WORK ORDER IN NATUS. (B)(4) FAILURE OVERALL. INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW DID SHOW ANOMALIES FOR THE COMPLAINT, INCLUDING A REVIEW OF ALL APPLICABLE MEASUREMENTS. FOR ALL STEPS REFERENCED ON WORK ORDER (B)(4) WHERE THE SCRAP PERCENTAGE EXCEEDED 1% A MEMBER OF THE SUPPORT OR ENGINEERING TEAM WAS NOTIFIED AND INVESTIGATED THE ISSUE BEFORE PRODUCTION RESUMED. OTHER COMPLAINTS FOR THIS SIMILAR ISSUE HAVE BEEN RECEIVED IN THE 12 MONTH PERIOD - RELATED CAPA005844.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT (B)(4) REF NATUS COMPLAINT# (B)(4). REVIEW AND CORRECTION TO INVESTIGATION DETAILS AS BELOW: PART MJT-2530-LL, LOT 0861414855 WAS BUILT ON WORK ORDER (B)(4). THE DEVICE HISTORY REVIEW SHOWS A TOTAL OF (B)(4) SCRAPED NEEDLES OF (B)(4) PRODUCED. THE SCRAP UNITS WERE ACROSS 7 STEPS OF THE WORK ORDER IN NATUS. TOTAL YIELD FOR THIS LOT POST PRODUCTION STEPS IN GORT IS 78.67%. MEDISIZE (CONTRACT MANUFACTURER) FAILED (B)(4) UNITS. (B)(4) UNITS DELIBERATELY SCRAPED FOR A PQ. TOTAL SCRAP AT MEDISIZE WAS 8.21%. THE BREAKDOWN OF REJECTS PER STEP IS AS FOLLOWS: STEP: 20, QTY: (B)(4), PERCENTAGE OF TOTAL: 7.7%, DESCRIPTION OF REJECT: UNITS WERE BENT BY MACHINE KOMAX 1. STEP: 40, QTY: (B)(4), PERCENTAGE OF TOTAL:1.05%, DESCRIPTION OF REJECT: TAPE AND DIPPING. PTFE COATING FAILURE. STEP: 70, QTY: (B)(4), PERCENTAGE OF TOTAL: 8.7%, DESCRIPTION OF REJECT: 30% GRIND UNEVEN & 70% PTFE DAMAGE DURING GRIND. STEP: 90, QTY: (B)(4), PERCENTAGE OF TOTAL: 0.54%, DESCRIPTION OF REJECT: 100% INSPECTION PER CRIMP. BLUNT REJECTS. STEP: 100, QTY: (B)(4), PERCENTAGE OF TOTAL: 0.52%, DESCRIPTION OF REJECT: CRIMP PULL TEST STEP: 110, QTY: (B)(4), PERCENTAGE OF TOTAL: 4.51%, DESCRIPTION OF REJECT: 100% INSPECTION POST CRIMP. 25% UNEVEN GRIND, 15% BLUNT TIP AND 60% POOR OR DAMAGED PTFE. THIS LOT OF MYOJECT NEEDLES WERE 100% INSPECTED 3 TIMES. 1ST BEFORE CRIMP AT STEP 90, THEN POST CRIMP AT STEP 110 AND FINALLY AT CONTRACT MANUFACTURER MEDISIZE. THE YIELD OF SCRAP IS DEEMED ACCEPTABLE AS PRODUCT IS 100% INSPECTED. NO UNIT OF THE FAILED PRODUCT WAS RETURNED. THEREFORE, ENGINEERING WAS UNABLE TO COMPLETE PRODUCT INVESTIGATION. FROM THIS INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY ANOMALIES FOR THE COMPLAINT INCLUDING A REVIEW OF ALL APPLICABLE MEASUREMENTS, THE DEFECT ITEM WAS NOT RETURNED AND OTHER COMPLAINTS FOR THIS ISSUE HAVE BEEN RECEIVED IN THE 12-MONTH PERIOD. CAPA005844 IS INVESTIGATING THIS ISSUE FURTHER AND WILL IDENTIFY ANY FURTHER CORRECTIVE/PREVENTIVE ACTIONS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT #(B)(4). PER (B)(4) REV L RISK ANALYSIS SPREADSHEET FOR NATUS MYOJECT DHN HAZARD ID 6.2 NEEDLES SHOULD BE SHARP. NEEDLE MAY BECOME BLUNTED/HOOKED/NEEDLES LOSING THEIR SHARPNESS EFFECT (HARM) PATIENT DISCOMFORT DURING PROCEDURE MAY INCREASE. RESIDUAL RISK: MODERATE. THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS IS MAINLY ASSOCIATED WITH THE NEEDLE HAVING WRONG SPECIFICATION/MANUFACTURING DEFECT. THE DEVICE IS DESIGNED AND MANUFACTURED TO MITIGATE THE RISK OF A FAULTY NEEDLE REACHING THE CUSTOMER AND THE RISK IS REDUCED AS FAR AS POSSIBLE BY PERFORMING 100% INSPECTION OF THE NEEDLES. THE REMAINING RISK ASSOCIATED WITH THE USE OF THE PRODUCT IS OUTWEIGHED BY THE BENEFIT OF ITS INTENDED USE. A QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO COMPLETE BUT NO RESPONSE. FOLLOW UP ATTEMPTS FOR THIS INFORMATION HAVE BEEN MADE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    TECA INJECTION NEEDLES - THE CUSTOMER RECENTLY NOTICED WHILE USING THE MJT-2530-LL, TEARING, RESISTANT AND CAUSING PAIN TO THE PATIENT.

    Description of Event or Problem · 0

    TECA INJECTION NEEDLES - THE CUSTOMER RECENTLY NOTICED WHILE USING THE MJT-2530-LL, TEARING, RESISTANT AND CAUSING PAIN TO THE PATIENT.

    Description of Event or Problem · 0

    TECA INJECTION NEEDLES: THE CUSTOMER RECENTLY NOTICED WHILE USING THE MJT-2530-LL, TEARING, RESISTANT AND CAUSING PAIN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301001 TECA INJECTION NEEDLES TECA INJECTION NEEDLES IKT NATUS MANUFACTURING LIMITED MJT-2530-LL 0861414855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other